Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05756283

The PREHAAAB Trial: Multimodal Prehabilitation for Patients Awaiting Open Abdominal Aortic Aneurysm Repair

An abdominal aortic aneurysm is a condition where the major artery in the abdomen becomes larger than usual. Over time, as it continues to grow, the wall of the artery weakens and there is a risk that the artery can burst causing internal bleeding and death. Aortic aneurysms are fixed when they reach a certain size to prevent that outcome. The surgery to fix them is a major, high-risk surgery that is associated with a lot of complications and a slow recovery back to normal. The time between diagnosis and surgery is called the pre-operative period and is a key time to optimize a patient's health in order to ensure the best possible outcomes following surgery. This study will look at whether a multidisciplinary pre-operative program that involves exercise training, nutritional advice and supplementation, and psychosocial support will reduce complications following surgery. This program should decrease complications and speed up a patient's recovery back to normal after surgery. It is also a way for patients to take ownership of their disease and play an active role in their health care journey. The benefits from this program will go beyond the pre-operative time frame, as the habits and knowledge gained will improve their health over their lifetime. This study will also assess the economic impact and cost of a program like this.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MUHC-RIMUHC Royal Victoria Hospital

Montreal, Quebec, H4A 3J1, Canada

About this study

Abdominal aortic aneurysms (AAA) are asymptomatic until they rupture, which carries an 80- 90% mortality. Therefore, AAA are surgically repaired when they reach 5.0 cm in women and 5.5cm in men. Despite advances to surgical technique and peri-operative care, open surgical repair still carries a high incidence of post-operative complications of 30-40%, and a long recovery period. This is largely because the surgery itself is major abdominal surgery, and these patients often have significant comorbidities and low functional status. Multimodal prehabilitation (MP) is a concept that uses the preoperative timeframe (between diagnosis and surgery) to optimize physical, nutritional, and emotional wellbeing to improve a patient's functional status and ability to withstand the stress of surgery. To date, there is no study evaluating the effect of MP on post-operative complications following open AAA repair.

The primary objective of this trial is to determine if MP will decrease complications as measured by the comprehensive complication index following open AAA repair compared to standard of care. This trial will also assess the effect of MP on functional capacity, hospital length of stay, 30-day mortality and health related quality of life, as well as to assess cost effectiveness, adherence, and fidelity to the intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants older than 50 years of age awaiting elective open AAA repair with AAA diameter ≤6.9cm. Participants should have the ability to give informed consent.

Exclusion criteria

  • Participants undergoing thoracic, thoracoabdominal and/or perivisceral AAA repair.
  • Participants with ruptured or symptomatic AAA.
  • Participants with AAA maximal diameter ≥7cm.
  • Physical inability to exercise: severe osteoarthritis, musculoskeletal or neurological impairment that precludes exercise.
  • Contraindication to exercise: rest systolic blood pressure ≥ 180 mmHg and/or diastolic ≥ 100 mmHg, uncontrolled atrial or ventricular arrythmias or proven exercise induced arrhythmias, unstable angina, unstable or acute heart failure, severe symptomatic valvular stenosis, dynamic left ventricular outflow tract obstruction or other comorbidities that imply clinical instability.
  • Cognitive impairment that would impede understanding of study procedures, informed consent or study questionnaires or the inability to effectively communicate in English/French/Spanish/Catalan.

Treatment and study plan

Multimodal prehabilitation

Behavioral

EXERCISE

  • Supervised exercise
  • High intensity interval training
  • Strength exercise
  • Home-based exercise / promotion of physical activity
  • Low-moderate intensity aerobic training
  • Inspiratory muscle training
  • Low-moderate intensity strength training

NUTRITION: nutrition education and optimization. Intake of 0.4g/kg of whey isolate after every supervised training.

PSYCHOSOCIAL: mindfulness, cognitive reframing and coping strategies.

Primary outcomes

  1. Postoperative complications measured by the Comprehensive Complication Index (CCI)

    Time frame: CCI will be measured from admission to 6 weeks postoperatively

    The CCI was developed to address some of the limitations of traditional surgical morbidity reporting, such as only reporting the most severe complication or only picking the most common types of complications. It is scored on a true linear interval scale from 0-100 and incorporates the totality of all complications and their severity experienced by a patient

Secondary outcomes

  1. ICU Length of stay

    Time frame: From admission to 6 weeks postoperatively

    Intensive Care Unit length of stay

  2. Hospital length of stay

    Time frame: From admission to 6 weeks postoperatively

    Days from admission to discharge from the hospital

  3. Reinterventions

    Time frame: from surgery day to 6 week postoperatively

    Need for surgical reintervention due to surgical complications

  4. Readmission

    Time frame: at 6 weeks and at 1 year postoperatively

    Readmission to the hospital

  5. Emergency Room visits

    Time frame: at 6 weeks and at 1 year postoperatively

    Visits to the emergency room with or without admission to the hospital

  6. 6-Minute Walk Test

    Time frame: Measured at baseline, preoperatively and 6 weeks postoperatively

    6-minute walk test

  7. VO2 peak

    Time frame: Measured at baseline and preoperatively

    Oxygen consumption at peak exercise

  8. VO2 AT

    Time frame: Measured at baseline and preoperatively

    Oxygen consumption at anaerobic Threshold

  9. VE/VCO2

    Time frame: Measured at baseline and preoperatively

    Minute ventilation/carbon dioxide production

  10. Yale physical activity survey (YPAS)

    Time frame: Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively

    Questionnaire of daily physical activity

  11. SF36

    Time frame: Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively

    Quality of life questionnaire

  12. Depression

    Time frame: Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively

    Depression measured by the Hospital Anxiety and Depression questionnaire (HADS) 0 (no depression)- 21 (maximal depression)

  13. Anxiety

    Time frame: Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively

    Anxiety measured by the Hospital Anxiety and Depression questionnaire (HADS) 0 (no anxiety)- 21 (maximal anxiety)

  14. Patient Generated Subjective Global Assessment (PG-SGA)

    Time frame: Measured at baseline, preoperatively

    Malnutrition assessment tool

  15. Compliance to intervention

    Time frame: Measured from baseline to preoperatively

    Compliance to the different components of the intervention, measured by attendance to supervised sessions (%), adherence to nutritional counseling and supplementation (%), adherence to home-based exercise (%) and adherence to the psychosocial sessions (%)

  16. Fidelity to exercise intervention

    Time frame: Measured from baseline to preoperatively

    Real training wattage and kg vs expected

  17. Height

    Time frame: Measured at baseline and preoperatively

    measurement of height in meters

  18. Weight

    Time frame: Measured at baseline and preoperatively

    measurement of Weight in kg

  19. Body Mass Index (BMI)

    Time frame: Measured at baseline and preoperatively

    Measurement of body mass index (weight and height will be combined to report BMI in kg/m^2)

  20. Body Fat percentage

    Time frame: Measured at baseline and preoperatively

    Measurement of body fat percentage using Bioelectrical Impedance Analysis

  21. Fat Free Mass (FFM)

    Time frame: Measured at baseline and preoperatively

    Measurement of body fa free mass in kg, using Bioelectrical Impedance Analysis

  22. Muscle Mass

    Time frame: Measured at baseline and preoperatively

    Measurement of muscle mass in kg, using Bioelectrical Impedance Analysis

  23. Phase angle

    Time frame: Measured at baseline and preoperatively

    Measurement of phase angle, using Bioelectrical Impedance Analysis

  24. Satisfaction and acceptability

    Time frame: Preoperative assessment

    Intervention satisfaction and acceptability questionnaire

  25. Incidents of adverse events (prehabilitation safety and tolerability)

    Time frame: Measured from Baseline to Preoperatively

    Incidence of adverse events and severe adverse events during prehabilitation program

  26. Quality adjusted life years

    Time frame: Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively

    Quality adjusted life years derived from SF36 data (SF6D)

  27. Prehabilitation cost-effectiveness

    Time frame: Measured at 1 year postoperatively

    Measurement of prehabilitation cost-effectiveness using data from SF6D, prehabilitation costs and hospitalization related costs.

Study contacts

Contact information is provided by the study sponsor or research team.

Heather Gill, MD

CONTACT

[email protected]

+1 514.934.1934 ext. 35113

Marie-Amelie Lucaszewski, PhD

CONTACT

+1 514.934.1934 ext. 35113

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

The PREHAAAB Trial: Multimodal Prehabilitation for Patients Awaiting Open Abdominal Aortic Aneurysm Repair - An International Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Mar 6, 2023
Registry last updated
Mar 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.